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November 1998

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Subject:
From:
Tony & Roz Cundell <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Mail List <[log in to unmask]>
Date:
Fri, 13 Nov 1998 19:18:47 -0500
Content-Type:
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The options that appear to be endorsed by the FDA are 20-25 degree C for 14
days or 20-25 degree C for 7 days followed by an additional 7 days at 30-35
degree C.

My preferance is to incubate at the higher temperature first to encourage
the rapid growth of the population most likely to be contaminants in an
aseptic processing area, i.e. bacteria derived from personnel, review the
media fill lot for massive aseptic processing control or even inspect the
containers prior to moving the lot to 20-25 degree C storage for a further 7
days to allow for fungal growth.

I have worked in microbiology lab where this incubation pattern is routinely
used for environmental monitoring.

I would like poll the group as to which incubation conditions you use.  Also
I would like to hear the rationale for using the lower temperature first.

Tony Cundell
Wyeth-Ayerst
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